BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1991989 · Received February 7, 2011

    Report

    Report Number
    2027969-2011-00266
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.6, REFERENCE: 2.77, MEAN: 2.69, CONFIDENCE LIMITS: 1.7-3.8. INRATIO: 0.8, REFERENCE: 1.40, MEAN: 1.10, CONFIDENCE LIMITS: 0.8-1.2. INRATIO: 1.2, REFERENCE: 1.20, MEAN: 1.20, CONFIDENCE LIMITS: 1.0-1.5. THE 3.4 AND 1.9 INR RESULTS WERE EXCLUDED FROM COMPARISON TEST SINCE NO CORRESPONDING INRATIO VALUE WAS PROVIDED. ANALYSIS OF CUSTOMER'S RESULTS REVEALED THAT ONE OUT OF THREE INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION COULD BE PERFORMED SINCE NO STRIP LOT INFORMATION WAS PROVIDED BY THE CUSTOMER. COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (SON OF PATIENT) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS. PATIENT WAS ADMITTED TO THE HOSPITAL AND PUT ON PAIN MEDICATION, MORPHINE ON (B)(6) 2011, THEN SHIFTED TO FENTANYL PATCH THE NEXT DAY. REASON FOR HOSPITALIZATION AND MEDICATION CHANGE WAS NOT STATED. DOCTOR ADJUSTED PATIENT'S COUMADIN FROM 7.5 MG TO 2.5 MG ON (B)(6) 2011. AFTER LAB RESULT OF 3.40 INR, DOCTOR DECIDED TO HOLD PATIENT'S COUMADIN, IN LIGHT OF A PROCEDURE THAT WAS GOING TO BE PERFORMED. PATIENT'S THERAPEUTIC RANGE: 2.5-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O